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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K232440
Device Name Adravision Perio
Applicant
Adra Corporation
1673 Mount Paran Rd NW
Atlanta,  GA  30327
Applicant Contact Yasaman Nematbakhsh
Correspondent
GM Consulting
1425 Golden Meadow Square
San Jose,  CA  95117
Correspondent Contact Moeini Golnaz
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/14/2023
Decision Date 12/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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